After introductions, Marty Monell provided the group some background information on why this workgroup of the Pesticide Program Dialogue Committee (PPDC) has been formed. The Pesticide Registration Improvement Act, at section 33(e), states that

“To the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks, the Administrator shall identify and evaluate reforms to the pesticide registration process under this Act with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Act of 2003 for pesticide registration actions for covered pesticide registration applications (including reduced risk applications).”

In identifying process improvements, the Agency will not compromise the scientific quality of its assessments as a means towards reducing decision time review periods. The Agency felt that, in terms of receiving recommendations for process improvements, the best means of gathering together suggested improvement areas was through the Federal Advisory Committee Act (FACA) process.Overview of Process Improvements Implemented Thus Far

Registration Division
The Registration Division (RD) began this session by providing a summary of 5 different process improvement areas that have already been implemented or are about to be implemented. Lois Rossi outlined these areas as: 1) process for fast track actions; 2) schedule for non-fast track actions; 3) schedule for new use (not first food use); 4) schedule for new active ingredient/first food use; and 5) IR-4 application process.

One major improvement area in the fast track process is that RD’s Technical Review Branch (TRB) now contacts registrants directly for minor deficiencies, with the goal of resolving them quickly. Historically when TRB identified deficiencies with studies or the confidential statement of formula, these deficiencies were communicated to the product manager who in turn communicated them to the registrant. Under this new process, if the minor deficiency can be resolved quickly, it is likely that RD will be able to complete its review with the decision time review period. If not, RD will be asking the registrant to renegotiate the clock. Some industry members of the workgroup noted that they are already seeing benefits from this new process.

RD then discussed the new processes for non-fast track actions, new uses, and new chemicals. One area that is improved with this new process is better communication on issues and milestones. The schedules call for actual team meetings, modeled on the current process used in the reregistration program. Planning activities for these actions will examine the level of effort (scoping); for example, how recently was a risk assessment done for the chemical; how similar is the chemical to another chemical that has already been registered. A meeting, called the “Registrant Meeting,” will also be held. RD anticipates that other stakeholders could be invited to this meeting as well, pending resolution of some confidentiality issues. These meetings could be used for problem formulation and to discuss data package completeness. In addition, the new schedules call for Data Evaluation Records (DERs) to be available at the time of registration.

For the non fast track process, RD believes that many can be handled within the division, however the registrants need to provide greater clarity regarding what they are seeking. RD is working on a suggested format for a cover letter that would provide these details. Industry representatives noted that often times the cover letter is not transmitted to the science evaluators. Under this new process, the science team would always receive these materials.

With the new IR-4 application process, the IR-4 program will coordinate the submission. The package from IR-4 will now contain the tolerance petition, the notice of filing, the registration application (including the label), and all supporting data. Registrants will submit their materials to IR-4 who will prepare the package and submit the materials to EPA. This process will ensure that these actions can be completed in the timeframe and avoids situations where the Agency, the registrants, and the IR-4 program are involved in lengthy interactions on administrative issues at the end of the review process.

Biopesticides and Pollution Prevention Division
Sheryl Reilly, Chief of the Biochemical Pesticides Branch in the Biopesticides and Pollution Prevention Division (BPPD) discussed some of the process improvements that BPPD has begun to implement. These include working through the backlog, establishing mentoring relationships between new staff and more experienced staff, the establishment of team captains for fast track and non-fast track actions, and the use of “expert teams” to sort through new incoming actions to determine what needs to be reviewed. BPPD is also developing schedules for various types of review actions. They are not currently available, however, BPPD intends to release them when they are ready. The division will also be communicating these schedules to the applicant.

Industry representatives inquired about the process for determining which division handles a combination product that contains both a biopesticide and a non-biopesticide. Sheryl explained that if the product is associated with a new pending active ingredient, BPPD handles the review. If the application is for a registered chemical, typically the determination is made based upon which active ingredient is more toxic.

Antimicrobials Division
Dennis Edwards, Chief the Risk Management Branch I in the Antimicrobials Division (AD) discussed how AD is looking at similar process improvements to those already discussed by RD and BPPD. In addition, for all new submissions, the division now holds a meeting to walk through the application, looking at the data and the labels, to determine whether the application is complete. The goal is to correct the applications upfront rather than at the tail end of the decision-making process. In addition for new active ingredients and new uses, the division is holding scoping meetings to determine what the application is about, whether the application warrants a scientific review, etc. If the decision is made that a scientific review is not necessary in a particular circumstance, the minutes from the meeting will be used to support the review of the application.

Consistent Label Review
This was identified as the highest priority by industry representatives. This was a common theme across all of the various trade associations. The principal issue here is that registrants receive different comments from different people. There appears to be inconsistent application of the Label Review Manual, Pesticide Registration Notices, and the regulations. Are the label deficiencies being identified editorial in nature vs. substantive. The proposal was to do an analysis to determine what kind of data might be useful to address these issues (to be discussed in Next Steps below). In conducting this analysis, it was suggested that you would need to also look at acceptances. A suggestion was made to consider the outcomes from the first round of the Consumer Labeling Initiative.

Product Chemistry Issues
One major issue here is the number of “cycles” between the registrant and the Agency, even for minor deficiencies. It was noted that RD’s new process will probably help a great deal in this area. Registrants would like training on how to fill out the CSF. They would also like better information regarding which inerts can be used in which types of formulations.

Communications
Registrants want to know where things are in the process, who is handling the action, etc. The preference would be for electronic notification. In addition, registrants noted that improvements are needed in the area of assigning Master Record Identification Numbers (MRID numbers). They would also like more information on the invoice and confirmation of the start date, particular for actions associated with waivers. Marty Monell noted that the Agency’s goal is to allow on-line status checks, but that this type of a system is at least 1-2 years away from implementation.

Access to Data Evaluation Records
Registrants need the DERs in order to address data deficiencies. The states also require the submission of the DERs. Inability to obtain the DERs can lead to delays in the state registration process. While registrants can obtain this information through the Freedom of Information Act (FOIA) process, they find this mechanism to be frustrating. In addition, registrants noted that the quality of some DERs can be an issue. The Registration Division has identified Terri Stowe as a point of contact for locating “old” DERs.

Electronic Submissions
There is the perception that the Agency’s interest in electronic submissions is dropping, although registrants noted that reviewer acceptance of electronic submissions appears to be increasing. They would like the Agency to explore other electronic submission mechanisms other that via CD. In particular, they noted the new process being implemented by Canada’s Pest Management Regulatory Agency (PMRA). Marty Monell noted that several representatives from the Agency would be traveling to Ottawa at the end of September to learn about this new process and to discuss Canada’s “lessons learned” from their cost-recovery program efforts.

Endpoint Selection
This area for improvement applies to both registration and reregistration. Registrants would like endpoints to be communicated before the completion of the risk assessment. Lois Rossi noted that she did not have a problem with this, but that we all needed to look at mechanisms to further open the registration process beyond registrants.

Endangered Species
The principal issue here was that the Agency needs to communicate a clearly defined process regarding the new counterpart regulation. Marty Monell noted that the Agency is currently training its staff regarding the new roles in the endangered species review process for the Environmental Fate and Effects Division (EFED) and the Field and External Affairs Division (FEAD). Subsequent to the meeting, Bill Jordan, Senior Advisor in the Office of Pesticide Programs, noted that the Agency will sponsor a workshop on Endangered Species Act issues, to be held on October 19, 2004.

Overall, the trade associations noted the overwhelming positive feedback they received when they polled their members.

Discussion of Process Improvements Proposed by EPA

The Agency had developed an initial set of five process improvements: 1) Incomplete data submissions; 2) Meeting PR Notice 86-5 requirements; 3) Improving documentation provided with registration applications; 4) Incomplete application forms; and 5) Improving label information. Regarding the first area, all agreed that more could be done in this area. The Agency received praise for HED’s DART process and EFED’s Rapid Response Team. There was some linkage between issue #1 and issue #2, as there was speculation that much of the 86-5 deficiency issues might be linked to the submission of supplementary materials.
Developing Criteria for Prioritizing Process Improvements

The workgroup began linking together process improvement areas identified by both industry and the Agency. Priority was given to the following process improvement areas:

Product Chemistry Reviews: The group felt that this overlapped nicely with the new process in the Registration Division. A related issue had to do with inert clearances but the group felt that the new Inerts Branch would likely resolve many of these issues. Some expressed a desire that a list of approved inerts that can be used in end-use products, both food use and non-food use, should be made available to the public.

Communication re: DERs and Endpoints: The workgroup supported RD’s new process for new active ingredients and new uses. AD said that they would explore establishing a single point of contact for DERs. The Agency indicating that this process improvement area needed to be coupled with opening up the registration process.

Next Step: Industry will develop a proposal on what could be done to make more information available pre-registration to a broader group of stakeholders.

Status of Pending Applications: The Agency will explore setting up a system, but noted that this could take 1-2 years before it was ready to be implemented. In particular, registrants would like to receive electronic communications regarding when the fee is received by the Agency and the start date for a registration action

Electronic Submissions: The Agency has issued the NAFTA templates. Some urged the Agency to gather data as to whether these templates were gaining efficiencies. One industry representative noted that the Agency should explore electronic submissions beyond new active ingredients, focusing on the “6-pack” of acute toxicity studies. The Agency also needs to work on electronic label review.

Next Steps:

The Agency should reintroduce stakeholders to opportunities for electronic submission. The Fall PRIA Workgroup could be one avenue. The Agency could also use this opportunity to update stakeholders on the study template profiles.

Consistent Label Review: Need to develop an approach to analyzing/collecting data on these issues. This issue will be paired up with the Agency’s process improvement regarding needing better label information.

Next Step: For the next meeting of the workgroup, the Agency will prepare a paper examining options for approaching/gathering data in this area.

Improving Quality of Applications: Various regulatory divisions have prepared submission screening “check lists”. These should be shared in the form of guidance with applicants. A suggestion was made that these could be added to the “registration kit” already on the Agency’s web page.

Comments from the Public

A consultant attending the meeting suggested that the Agency look towards improving the registration fee waiver process. The Agency noted that the new industry developed form is helping improve the process. The consultant was asked to develop a problem statement and submit it for the workgroup’s consideration.

Additional Next Steps

The next meeting of the workgroup will be scheduled for October 12, 2004. At this meeting, the workgroup will develop the initial set of recommendations, to be presented at the October meeting of the PPDC.